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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01495949
Other study ID # Si559/2011
Secondary ID
Status Completed
Phase Phase 4
First received December 13, 2011
Last updated May 21, 2014
Start date December 2011
Est. completion date December 2013

Study information

Verified date May 2014
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

During induction for cardiac surgery, patient hemodynamic stability is achieved by using anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate. Etomidate although has been used for a long time but its safety regarding cortisol synthesis suppression is still doubtful. This study measures the changes in cortisol levels during cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive agents (etomidate and thiopentone). Recording data also include hemodynamic changes during induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount of insulin usage, length of ICU and hospital saty.


Description:

Ninety-two cardiac patients who undergoing cardiopulmonary bypass graft (CABG) or valve surgery will be enrolled in this study. They will be randomized into two groups (thiopentone and etomidate groups). Apart from different in two inductive drugs, other anesthetics will be the same. We record hemodynamic changes during inductions, inotropic use (dose and duration), blood glucose levels, total insulin requirement to keep blood glucose 140-180 mg% in perioperative period, duration of mechanical ventilation, length of stay in ICU and total hospital length of stay. The changes in cortisol levels will be recorded at time 0 (before induction), 2, 4, 8, 24 hours in 26 patients (13 patients in each group and only patients who are the first in the operating list (morning list)).The 26 patients is needed from sample size equation for the changes in cortisol level and the 92 patients is calculated from the differences in inotropic use.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria:

60 year or older cardiac patient undergoing cardiac surgery (CABG or valve surgery) with the use of cardiopulmonary bypass -

Exclusion Criteria:

- Redo or emergency operation

- complex and prolong operation

- history of adrenal insufficiency or steroid use

- already has inotropic drugs to support hemodynamics

- creatinine > 2.0 mg/dl

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
etomidate
During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 2-4 mg (1-2 ml) of etomidate will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious.
thiopentone
During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 25-50 mg (1-2 ml) of thiopentone will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious

Locations

Country Name City State
Thailand Siriraj Hospital Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary cortisol levels Measure cortisol levels and its changes due to stress response during surgery. Compare the changes in cortisol levels between two induction agents (etomidate and thiopentone). baseline (before induction), 2, 4, 8, and 24 hrs Yes
Secondary the use of inotropes for maintaining hemodynamic The dose and duration of inotropic drug (S) used for maintaining hemodynamic during coming off cardiopulmonary bypass and postoperative period. 24 hours Yes
Secondary Length of ICU and hospital stay 30 days No
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